Paragon 28, Inc. recalls
Every recall we track for Paragon 28, Inc. — 13 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
13 recalls since 2017.
All FDA recall records for Paragon 28, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 1 | 1 | 1 | 3 |
| 2023 | 0 | 0 | 0 | 3 | 3 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 1 | 0 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 3 | 0 | 3 |
Most common reasons for Paragon 28, Inc. recalls
What to do if you have a recalled Paragon 28, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Paragon 28, Inc. recalls
10 shown- Lower riskMedical device
Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Paragon 28 recalls a specific foot implant model due to elevated oxygen levels potentially reducing material strength. Affected units include Lot AOCIA6123.
Paragon 28Jul 10, 2026 - Lower riskMedical device
Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm,
Paragon 28 recalls P28 Phantom Hindfoot Nail System due to potential sterile packaging breaches. Affected units have specific model and lot numbers. Consumers should check their product details and contact the company for guidance.
Paragon 28Jun 17, 2026 - Use cautionMedical device
Paragon 28, Inc. recalls Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Paragon 28 recalls Phantom Fibula Nails with improper thread depth that could require surgery abortion. Affected items have specific model and lot numbers. Contact for remedy.
Paragon 28Oct 13, 2025 - UnratedMedical device
Paragon 28, Inc. recalls Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Paragon 28 recalls Phantom TTC Nails distributed before sterilization. These medical devices pose a risk of infection due to improper sterilization. Affected units include specific model and reference numbers.
Paragon 28Dec 21, 2023 - Use cautionMedical device
Paragon 28, Inc. recalls Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture
Paragon 28 recalls titanium suture anchors that may break during surgery, causing debris and delays. Affected kits include REF P44-110-3010-SK. Contact for return instructions.
Paragon 28Jul 13, 2022 - UnratedMedical device
Paragon 28, Inc. recalls HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Paragon 28 recalls HammerTube Implant 2.75mm cannulated (sterile) due to missing titanium coating. Affected units have specific part numbers and lot numbers. Consumers should contact for details.
Paragon 28May 26, 2022 - Lower riskMedical device
Paragon 28, Inc. recalls Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc:
Paragon 28 recalls Baby Gorilla/Gorilla Plating System (Ref: P99-100-2816) due to potential incorrect part numbers in drill packaging. Affected units may have wrong labels.
Paragon 28May 18, 2022 - Lower riskMedical device
Paragon 28, Inc. recalls Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Paragon 28 recalls Phantom Nail System Drills with thin wall condition that may fracture, risking injury. Affected models include P99-110-4630.
Paragon 28Jul 30, 2021 - Lower riskMedical device
Paragon 28, Inc. recalls P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182,
Paragon 28 recalls 10mm wedge implant kits labeled as 12mm to prevent surgical errors. The mislabeling risks improper surgical site preparation and delays in procedures.
Paragon 28Sep 28, 2018 - Lower riskMedical device
Paragon 28, Inc. recalls P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones
Paragon 28 recalls JAWS Nitinol Staple System kits for foot bone repairs due to missing drill guide in some models. Affected kits include specific part numbers and production lots. Consumers should check their kit details and contact Paragon 28 for guidance.
Paragon 28Dec 19, 2017
Paragon 28, Inc. recall questions
How many recalls has Paragon 28, Inc. had?
13 recalls from Paragon 28, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Paragon 28, Inc. recall?
Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant, dated Jul 10, 2026. Every Paragon 28, Inc. recall is listed on this page, newest first.
Why are Paragon 28, Inc. products recalled?
The most common reasons on record: Medical devices distributed, prior to sterilization (3).
What should I do if I have a recalled Paragon 28, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Paragon 28, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.